Spacelabs Qube Compact Patient Monitor Recalled for Input Circuit Failure
Spacelabs Healthcare is recalling Qube Compact Patient Monitors because the input circuit may fail, causing the device to shut down when batteries deplete or fail to turn on.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that may shut down or fail to turn on, posing a risk of harm to patients if monitoring is interrupted, though no specific injuries are reported in the source text.
Plain-English summary
Spacelabs Healthcare, LLC is recalling the Qube Compact Monitor (Model 91390) patient monitors. The recall is due to reports that the input circuit may fail, causing the monitor to switch to battery mode. If the batteries become depleted, the monitor will shut down. Additionally, the monitor may fail to turn on due to an internal short.
A total of 742 devices were distributed, with 530 in the United States and 212 internationally. The devices are intended for use in hospital environments under the supervision of licensed healthcare practitioners. The monitors display data from parameter modules and interfaces, including ECU, respiration, blood pressure, SpO2, temperature, and cardiac output.
Healthcare facilities should check their inventory for the affected serial numbers listed in the FDA recall notice. If a device is affected, it should be removed from service and Spacelabs Healthcare should be contacted for a field corrective action. The firm has advised FDA that specific serial numbers were added to the recall list as replacements for a French customer, which also require the corrective action.
The recalled product
- Product
- qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor
- Manufacturer
- Spacelabs Healthcare, Llc
- Category
- Medical Device — Patient Monitor
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers for devices distributed in the US: 1390-000102
- 1390-000103
- 1390-000104
- 1390-000105
- 1390-000106
- 1390-000107
- 1390-000108
- 1390-000109
- 1390-000110
- 1390-000111
- 1390-000112
- 1390-000113
- 1390-000114
- 1390-000115
- 1390-000116
- 1390-000119
- 1390-000120
- 1390-000150
- 1390-000151
- 1390-000152
Distribution
Distribution scope not specified by the agency.
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